April 2022: Varwere vakuru vane kenza yemazamu isingagadziriswe kana metastatic HER2-positive vakagamuchira pre-anti-HER2-based regimen ingave mune metastatic setting, kana neoadjuvant kana adjuvant setting uye vakagadzira kudzoka kwechirwere mukati kana mukati memwedzi mitanhatu yekupedza kurapa kwave. yakapihwa fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) neFood and Drug Administration.
DESTINY-Breast03 (NCT03529110) yaive multicenter, yakavhurika-label, randomized muedzo iyo yakanyoresa 524 varwere vane HER2-yakanaka, isingagadziriswi, uye / kana metastatic cancer yemazamu avo vakambogamuchira trastuzumab uye taxane kurapwa kwechirwere chemetastatic kana kuve nechirwere chekudzoka panguva kana mukati memwedzi mitanhatu yekupedza neoadjuvant kana adjuvant therapy. Varwere vaipihwa Enhertu kana ado-trastuzumab emtansine nemutsinga mavhiki matatu ega ega kusvika muchetura usingashiviriki kana kukura kwechirwere. Hormone receptor mamiriro, kurapwa kwepertuzumab kwepamberi, uye nhoroondo yechirwere chevisceral yakashandiswa kurongedza maitiro ekuita.
Progression-free survival (PFS) ndiyo yaive nhanho yekutanga yekubudirira, sezvakatsanangurwa neyakapofumadzwa yakazvimirira yepakati wongororo uchishandisa RECIST v.1.1 scoring system. Iwo ekutanga echipiri mhedzisiro matanho aisanganisira kupona kwese (OS) uye yakasimbiswa chinangwa chekupindura mwero (ORR). Ruoko rweEnhertu rwaive nepakati PFS isina kuwanikwa (95 muzana yekuvimba nguva: 18.5, isingafungidzike) uye ado-trastuzumab emtansine ruoko yaive nepakati PFS yemwedzi 6.8 (95 muzana yekuvimba nguva: 5.6, 8.2). Chiyero chengozi chaive 0.28 (95 muzana yekuvimba nguva: 0.22 kusvika 0.37; p=0.0001). 16 muzana yevarwere vakanga vafa panguva yePFS yekudzidza, apo OS yakanga ichiri mucheche. The Enhertu ruoko rwaive neORR ye82.7 muzana (95 muzana CI: 77.4, 87.2) pakutanga, nepo avo vaigamuchira ado-trastuzumab emtansine vaive neORR ye36.1 muzana (95 muzana CI: 30.0, 42.5).
Nausea, kupera simba, kurutsa, mhanza, kuvharwa, anemia, uye musculoskeletal kusagadzikana ndizvo zvakajairika zviitiko zvakaipa (chiitiko> 30 muzana) muvarwere vanotora Enhertu. Kurutsa, interstitial mapapu chirwere, mabayo, pyrexia, uye weti tract infection zvaive zvakakomba mhedzisiro mune inodarika 1% yevarwere vakawana Enhertu. Yambiro Yebhokisi pamirayiridzo yekuraira inoyambira vanachiremba nezve mukana wechirwere chemapapu chepakati uye kukuvara kwe "embryo-fetus".
Enhertu inopiwa semutsinga wemutsinga kamwe chete mumavhiki matatu (21-day cycle) kusvikira chirwere chakura kana kuti muchetura usingagamuchirwi.
Wona ruzivo rwakazara rwekurayira Enhertu.
